| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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055
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Date of Entry 12/21/2020
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FR Recognition Number
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19-37
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| Standard | (Included in ASCA) |
IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
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Scope/AbstractThis International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE.
NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property (e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration.
This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.
This collateral standard does not specify:
- additional mechanical requirements; or
- additional electrical requirements.
This collateral standard applies to a closed-loop controller (see Figure 1) that sets the CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE.
A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is not measured from a PATIENT, is outside the scope of this standard. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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FDA Specialty Task Groups (STG)
| General II (ES/EMC) (primary) |
| Anesthesiology |
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| *These are provided as examples and others may be applicable. |
